![]() Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. ![]() Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Give the lowest effective dose.įULL PRESCRIBING INFORMATION: CONTENTS * WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Important Administration Instructions 2.2 Important Considerations for Dosing 2.3 Recommended Dosage and Titration 2.4 Monitoring TSH and/or Thyroxine (T4) Levels 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Serious Risks Related to Overtreatment or Undertreatment with Levothyroxine Sodium Tablets 5.2Ĝardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease 5.3 Myxedema Coma 5.4 Acute Adrenal Crisis in Patients with Concomitant Adrenal Insufficiency 5.5 Worsening of Diabetic Control 5.6 Decreased Bone Mineral Density Associated with Thyroid Hormone Over-Replacement 5.7 Risk of Allergic Reactions Due to Tartrazine 6 ADVERSE REACTIONS 7 DRUG INTERACTIONS 7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics 7.2 Antidiabetic Therapy 7.3 Oral Anticoagulants 7.4 Digitalis Glycosides 7.5 Antidepressant Therapy 7.6 Ketamine 7.7 Sympathomimetics 7.8 Tyrosine-Kinase Inhibitors 7.9 Drug-Food Interactions 7.10 Drug-Laboratory Test Interactions 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone resorption and decrease bone mineral density. ![]() Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy. Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements.Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of levothyroxine sodium treatment.Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma.Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate levothyroxine sodium at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation.Serious risks related to overtreatment or undertreatment with levothyroxine sodium tablets: Titrate the dose of levothyroxine sodium carefully and monitor response to titration.
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